Kornimate/medical-research-clean huggingface dataset:
efficacy of 500µg roflumilast once daily versus placebo over 12 weeks in patients with diabetes mellitus type 2. a double blind, parallel group, proof of concept clinical study

Conditions: Diabetes Mellitus Type 2

Summary: this study is a proof of concept study to confirm in a standardized manner the therapeutic efficacy of roflumilast in type 2 diabetes mellitus patients.


Eligibility criteria:
inclusion criteria: * given written informed consent * patients with diagnosis of type 2 diabetes according to american diabetes association (ada) criteria and inadequately controlled on diet and exercise alone * hba1c at baseline: ≥7.5 percent to 8.5 percent (up to 9 percent in mexico, ukraine and romania) * bmi between ≥26 and ≤35 kg/m2 * willingness of patient to check his/her blood glucose with equipment provided by the sponsor during the treatment phase in case of hypo-/hyperglycemia episodes * willingness to adhere to the physician's advise to comply with diet and exercise main exclusion criteria: * patients diagnosed with type 1 diabetes or diabetes secondary to pancreatitis or resection of pancreas * patients diagnosed with hemoglobinopathies, hemolytic anemia or other diseases which interfere with hba1c measurement * non-euthyroid patients or patients with a non-controlled hypo- or hyperthyroidism * reported gain or loss of more than 5 percent of body weight within the last 2 months prior to v0 * treatment with any diabetes medication prior to v0 * treatment with any weight-loss medication within 3 months prior to v0 * treatment with any not allowed medication or nutrition additives * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator) * clinically significant cardiac abnormalities (diagnosed clinically, or by x-ray/ecg) that were not related to type 2 diabetes mellitus and that required further evaluation * participation in a clinical study with study medication for weight loss or type 2 diabetes patients were randomized after 2 weeks of the baseline period, if the following criteria were fulfilled: * judged to be clinically stable * tablet compliance ≥80 percent and ≤125 percent * hba1c in the range of 7.5 percent to 8.5 percent (up to 9 percent in mexico, ukraine and romania) tested at v0 by the central laboratory

Keywords: diabetes mellitus type 2 roflumilast
efficacy, safety, tolerability of pegaptanib sodium (macugen) in filipino patients with neovascular age related macular degeneration.

Conditions: Neovascular Age-related Macular Degeneration

Summary: an open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(macugen) in the treatment of filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.

open-label, non-comparative, non-interventional study

Eligibility criteria:
inclusion criteria: * must have at least one eye which was diagnosed with neovascular degeneration exclusion criteria: * presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis

Keywords: a5751025
factors predicting recurrence in rectal cancer after surgery

Conditions: Rectal Cancer; Rectal Adenocarcinoma

Summary: colorectal cancer is one of the most frequently diagnosed cancers and a major cause of cancer deaths worldwide. recurrence after curative surgery is one of the major factors affecting the long-term survival and its frequency is estimated to be 22.5% at 5 years. of which 12% have local recurrence. the overall survival in case of recurrence of 11% at 5 years. several patient-, tumor-related and treatment-related prognostic factors have been found to be associated with the risk of recurrence of rectal adenocarcinoma. some of these factors such as tnm stage, lymphatic and perineural invasion and vascular emboli have been found to affect recurrence free survival in most studies. while the impact of other factors such as distal resection margin, tumor size, extra capsular spread and neoadjuvant chemoradiotherapy on recurrence remains controversial. moreover, most of the previous studies on prognostic factors have been from american and european countries with very little data from african countries. recognition of these factors helps in identification of high-risk patients who require close and more rigorous postoperative surveillance. hence this study was conducted to determine the factors affecting recurrence after curative resection of rectal cancer in african population.


Eligibility criteria:
inclusion criteria: - all the patients who underwent curative resection for rectal adenocarcinoma between january 2000 and december 2015 at the department of digestive and visceral surgery of sahloul hospital, sousse, tunisia exclusion criteria: * patients who underwent palliative surgery * patients with microscopically or macroscopically positive resection margin * patients with tumors other than adenocarcinoma * patients who died in the postoperative period due to complications.

Keywords: rectal adenocarcinoma recurrence prognosis
topical tacrolimus 0.1% ointment for treatment of cutaneous crohn's disease

Conditions: Crohn Disease

Summary: an assessment of the efficacy of topical tacrolimus in the treatment of cutaneous crohns disease


Eligibility criteria:
inclusion criteria: * willingness and capability to follow the study procedure * confirmed diagnosis of crohn's disease of at least 3 months duration confirmed by radiography, endoscopy or pathological examination * required to have a skin manifestation of crohn's disease * required to give written informed consent * both male and female subjects with reproductive potential required to be on an acceptable form of birth control for the duration of the study * long-standing, concomitant immunosuppressive therapy was allowed if the dose was stable and not controlling the skin problem exclusion criteria: * known sensitivity to tacrolimus * change in aminosalicylate dosage in the four weeks prior to screening * on oral steroids at over 40mg per day * been commenced on methotrexate, azathoprine or ciclosporin within the last two months * commenced on a a tnf-alpha monoclonal antibody within the three months prior to screening * patients having had a stoma fashioned less than three months before enrolment * patients with an immunocompromising disease * patients with a diagnosis of malignancy within the last five years * patients with any other condition, past or present treatment thought by the investigator to render the subject ineligible for the study

Keywords: cutaneous crohns disease topical tacrolimus protopic metastatic crohns disease pyoderma gangrenosum granulomatous chelitis oral crohns disease perianal crohns disease
physiotherapy in vestibular disorders

Conditions: Vestibular Disorder

Summary: spanish population with unilateral peripheral vestibular disorders.

participants with peripheral vestibular disorders will be allocated to a cawthorne and cooksey exercises protocol or control group. the cawthorne and cooksey exercises consist in some head mobilization and positioning tasks which are related with a restoration of vestibular disorders.

Eligibility criteria:
inclusion criteria: * participants with with unilateral peripheral vestibular disorders exclusion criteria: * bilateral vestibular disorders * fluctuating or active unilateral vestibular disease * or other medical conditions in the acute phase were excluded from the study.
ssvep evaluation of brain function

Conditions: Mild Traumatic Brain Injury

Summary: the investigational device used in this clinical investigation, the nurochek headset, is a portable electroencephalogram (eeg) headset which delivers a visual stimulus and measures a vep. the visual stimulus is delivered to the subjects' eyes via light-emitting diodes, and the eeg measures the user's visual-evoked potential. this headset communicates with an application on a smartphone which processes the signals and transmits them to a secure cloud server for analysis and storage of the data. the primary objective of this clinical investigation was to evaluate the performance of the investigation device (ncii) against clinical diagnosis and scat 5, in the accurate detection of mild traumatic brain injury (mtbi). the primary endpoint outlined for this study was set at the collection of 100 valid investigational device readings from individuals with concussion the aim of this study was to collect data from 100 readings from individuals with concussion. it was estimate that approximately 10-20% of baselined players would suffer a concussion during the season. there it was estimated there would be a need to baseline 500-1000 individuals in order to achieve the number of concussions required. the initial assumption was that sites would provide players pre-season and make players available for testing post-concussion. in practice, some sites provided player data only post-concussion event (such as medical clinics). participants were required from sporting clubs, medical clinicals and schools.


Eligibility criteria:
inclusion criteria: * individuals aged 14 years and older, participating in sport-related activities. exclusion criteria: * individuals were excluded if they had a history of seizures, history of epilepsy, structural brain injuries, legal blindness, or sensitivity to flashing lights.

Keywords: mild traumatic brain injury concussion steady state visual evoked potential electroencephalography sports concussion sports medicine
efficacy of ropivacaine (with epinephrine) in baba endoscopic and robotic thyroidectomy

Conditions: Thyroid Neoplasm; Goiter

Summary: to assess the pain relief and the hemodynamic stability of ropivacaine with epinephrine in baba endoscopic and robotic thyroidectomy.

diluted ropivacaine with epinephrine is injected into the subcutaneous space to relieve pain and reduce bleeding during procedures. the synergistic effect of ropivacaine with epinephrine can contribute to patients' welfare, such as relieving pain and structuring the hemodynamic stability.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of thyroid neoplasm or benign goiter * scheduled for baba endoscopic or robotic thyroidectomy exclusion criteria: * completion thyroidectomy * modified radical neck dissection * allergy history * stroke history * uncontrolled hypertension * uncontrolled diabetes * coagulopathy * severe cardiovascular disease * severe pulmonary disease * chronic kidney disease * pregnant

Keywords: ropivacaine epinephrine endoscopy robotics thyroidectomy
assessment of local anaesthesia effectiveness in symptomatic irreversible pulpitis

Conditions: Symptomatic Irreversible Pulpitis

Summary: this study aims to evaluate the comparative efficacy of two different local anaesthetic agents for supplemental buccal infiltration after a failed inferior alveolar nerve block in achieving profound pulpal anaesthesia for symptomatic irreversible pulpitis using 2% lignocaine and 4% articaine with vasoconstrictor epinephrine. alternate hypothesis: there is a mean difference in local anaesthesia effectiveness of 2% lignocaine and 4% articaine containing epinephrine when used for buccal infiltration in pulpectomy of symptomatic irreversible pulpitis of mandibular posterior teeth after a failed inferior alveolar nerve block

patients diagnosed with symptomatic irreversible pulpitis are included in this study. teeth will be divided into two groups after a failed inferior alveolar nerve block using 2% lignocaine containing 1:100,000 epinephrine. a sample size of 123, with the first group consisting of 62 patients, 2 cartridges of 32mg of 2% lignocaine with 1:100,000 epinephrine will be used for supplemental buccal infiltration. in group 2 of 61 patients, 40mg of 4% articaine with 1:100,000 epinephrine will be used. during the root canal treatment, a subjective assessment of lip anesthesia is recorded. an electric pulp tester is used for the evaluation of the presence or absence of pulpal anesthesia. a verbal analogue scale is also used to evaluate the presence or absence of pain. after taking a brief history, informed consent will be taken. a rubber dam will be used. electric pulp tester will be used on the control contralateral tooth, the experimental tooth preoperatively; after giving nerve block and achieving lip numbness, the experimental tooth will again be evaluated with electric pulp tester. an access cavity will be made. if there is still no pulpal anesthesia, supplemental anesthesia will be administered and electric pulp tester will be used again. a questionnaire containing a numerical rating scale will be given to each patient to record the intensity of pain felt after giving supplemental anesthesia.

Eligibility criteria:
inclusion criteria: 1. patients with ages ranging from 18-to 55 years 2. male/ female 3. mandibular posterior teeth with symptomatic irreversible pulpitis 4. ability to understand the use of the pain scale 5. patients with adequate oral hygiene and willing to participate in the study exclusion criteria: 1. any type of medication consumed before treatment 2. patients who do not show profound lip numbness after giving inferior alveolar block 3. periapical pathologies ( periapical abscess, sinus tract, periapical cyst, pulpal necrosis) 4. external resorption 5. unfavorable location of the tooth, internal ankylosis, trismus, severe tooth malposition.

Keywords: lignocaine, articaine and supplemental buccal infiltration
expanded access to triheptanoin

Conditions: Long Chain Fatty Acid Oxidation Disorders

Summary: expanded access may be provided for qualified patients who have limited treatment options and are not eligible for a clinical trial.

long chain fatty acid oxidation disorders (lc-faod) and other non-faod conditions, where applicable: expanded access may be available outside of the us in countries prior to approval by the local regulatory agencies. for full details, please visit the links provided below.

Eligibility criteria:
- the participant must not be eligible for a ux007 clinical trial

Keywords: expanded access compassionate use carnitine palmitoyltransferase deficiency cpt i cpt ii very long chain acyl-coa dehydrogenase deficiency vlcad long chain 3-hydroxy-acyl-coa dehydrogenase deficiency lhcad trifunctional protein deficiency tfp carnitine-acylcarnitine translocase deficiency cact lc-faod
patient satisfaction survey of non-surgical urinary incontinence treatment

Conditions: Urinary Incontinence

Summary: the purpose of this study is to identify self-reported wellness following nonsurgical treatment of stress urinary incontinence. this will be done by correlating the response of "yes" on the patient acceptable symptom state (pass) question to responses from other questionnaires regarding urinary symptoms.


Eligibility criteria:
inclusion criteria: * adult women (\> 18 years) seeking care for stress urinary incontinence at the urmc in rochester, ny, dumc in durham, nc, western new york (wny) urology associates in cheektowaga, ny, or at the utmb in galveston, tx. * english-speaking * possess the ability to complete electronic patient reported outcome questionnaires and voiding diaries exclusion criteria: * women who decline to participate in the study * women were unable to complete electronic patient reported outcome questionnaires * women with greater than stage ii uterovaginal prolapse or post-hysterectomy prolapse. * women considered citizens of the european union (eu), including eu citizens living in the united states.
pharmacokinetic study of tranexamic acid

Conditions: Ovarian Neoplasm Epithelial

Summary: tranexamic acid is an effective anti fibrinolytic drug. clinical studies have found that intravenous injection of tranexamic acid is more effective in reducing blood loss and transfusion in patients with advanced ovarian cancer, without increasing the risk of postoperative complications. different surgeries and administration routes have an impact on the pharmacokinetics and pharmacodynamics of txa. at present, there is little data on the pharmacokinetics of intramuscular injection of txa, and almost all of the data comes from males. for ovarian cancer patients, there are currently no reports on the pharmacokinetics of txa through different routes of administration, such as intramuscular and intravenous administration. therefore, the investigators chose ovarian cancer patients and administered it through different routes of intravenous and intramuscular injection.

the investigators plan to recuit 30 patients, administered txa through different routes of administration. then pharmacokinetic parameters of different txa administration routes were recorded. to study the effects of different txa administration routes on intraoperative blood loss, transfusion volume and postoperative adverse outcomes (thrombosis, etc.) in ovarian cancer patients undergoing cell reduction surgery.

Eligibility criteria:
inclusion criteria: 1. adult women aged 20-64 diagnosed with advanced ovarian cancer undergoing cytoreductive surgery 2. the cancer stage is iii-iv 3. asa classification ii-iii 4. surgical duration\>2 hours exclusion criteria: 1. renal dysfunction (serum creatinine\>200 mmol/l) or liver dysfunction (child turcote classification\>6) 2. has a history of serious mental illness or disorders, epilepsy, visual impairment 3. previous or current bleeding disorders, coagulation dysfunction, or thromboembolic events 4. lower limb venous thrombosis 5. anticoagulants or antifibrinolytic drugs used before surgery within the past month 6. allergic to txa

Keywords: tranexamic acid pharmacokinetics
functional diagnostic accuracy of ultrasonic flow ratio in assessment of coronary artery lesions

Conditions: Coronary Artery Stenosis

Summary: this is a prospective, single-center study. the primary purpose of this study is to evaluate the sensitivity and specificity of offline computational ultrasonic flow ratio (ufr) with conventional pressure wire-based fractional flow reserve (ffr) as the standard reference. the study will be conducted in fuwai hospital, and a total of 408 patients with coronary vessel diameter stenosis ≥30% and ≤80% are planned to be recruited. participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (ivus) followed by ffr examination. ivus imaging will be sent to an independent core laboratory for ufr calculation. ufr analyses were performed offline in a blinded fashion without awareness of ffr measurement. using ffr≤0.80 as the gold standard, the sensitivity and specificity of ufr in the functional significance of coronary artery stenosis will be analyzed.


Eligibility criteria:
inclusion criteria: * stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction * age ≥18 years * written informed consent * intermediated coronary lesions (diameter stenosis of 30%-80% by visual estimation from coronary angiography) exclusion criteria: * ineligible for diagnostic ivus or ffr examination * prior coronary artery bypass grafting of the interrogated vessels * myocardial infarction within 72 h of coronary angiography * severe heart failure * serum creatinine levels \>150 umol/l, or glomerular filtration rates \<45 ml/kg/1.73 m2 * allergy to the contrast agent or adenosine * life expectancy \< 2 years * ivus pullback not covering the entire lesion * severe myocardial bridge in the interrogated vessel

Keywords: intravascular ultrasound ultrasonic flow ratio fractional flow reserve
diagnostic accuracy for hemodynamically icas of mr-ffr comparing with pressure-wire-based ffr.

Conditions: Stroke, Ischemic; Intracranial Atherosclerosis

Summary: the aim of this study was to determine the diagnostic accuracy of mr-ffr to detect functionally significant icas comparing with pressure-wire-based ffr.

this study will perform a head-to-head comparison between mr-ffr and pressure-wire-based ffr in patients with icas. pressure-wire-based ffr will be used as the gold standard for intravascular pressure gradient measurement. the efficacy and safety of non-invasive ffr will be assessed in this study.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years or older. 2. patients with transient ischemic attack (tia) or nondisabling ischemic stroke caused by a focal icas lesion located in intracranial anterior circulation (intracranial internal carotid artery and their major branches). 3. 50% to 99% stenosis (calculated by modified wasid method) of responsible arterial occlusion, confirmed by digital subtraction angiography (dsa). 4. informed of the study protocol and objectives. exclusion criteria: 1. non-atherosclerotic mca stenosis 2. combined with moderate or severe stenosis of other extracranial and intracranial arteries 3. previous endovascular treatment or surgery for cerebrovascular diseases 4. large cerebral infarction (more than 1/2 mca perfusion area) 5. combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection. 6. vascular abnormality or stunting, resulting in the impossibility of endovascular intervention 7. liver and kidney dysfunction, or severe allergy to the contrast agent 8. severe coagulation dysfunction 9. pregnancy or in the preparation for pregnancy 10. patients who cannot tolerate or do not allow mr screening, including metal implanting and claustrophobia 11. patients with severe dementia or mental disorders, who cannot cooperate with examination

Keywords: intracranial atherosclerotic diseases fractional flow reserve
clinical validation study of multi-epi mix

Conditions: Brain Diseases

Summary: this study aims to assess the diagnostic validity of a new minute-mri sequence for neuroradiological evaluation in comparison to conventional mri.

the study aims to assess the imaging quality with regards to artefacts and lesion conspicuity as well as its diagnostic potential in rendering a probable diagnosis. the primary study aim is to define the auc for diagnostic performance of minute mri compared to conventional mri. included patients are those with suspiscion of cerebral pathology. study participancts are investigated at 3t.

Eligibility criteria:
inclusion criteria: - neuroradiological mri exclusion criteria: - aborted exam

Keywords: mri neuroradiology minute-mri multi epi-mix clinical validation
joyof art - an intervention study

Conditions: Quality of Life; Family Caregivers

Summary: music, dance and visual arts are suggested to support health and well-being of older people. intervention studies, however, are scarce. joy of art study investigates the effects of multicomponent art intervention among older people and ther family caregivers.

joy of art study investigates the effects of group based intervention including music, dance and visual arts. art sessions are provided once a week in three months period each session takes 60 minutes. eligible participants are recruited from the city of kuopio, finland, total 60 dyads, 30 to intervention group and 30 to control group. health, physical performance and quality of life assessments are conducted at the baseline and in the end of the intervention. in addition, participants are contacted by phone and interviewed six months after the intervention has completed. for family caregivers qualitative interviews are conducted at the baseline and in the end of the study.

Eligibility criteria:
inclusion criteria: * 65+ age, family caregiving dyad, ability to walk independently or assisted, home dwelling exclusion criteria: * severe dementia, severe aphasia

Keywords: art intervention quality of life well-being physical performance family caregivers older adults